JOSEPH S. MACHI
North Bergen,NJ
Summary
Quality and Compliance Leader with over 20 years of experience enabling pharmaceutical, biopharmaceutical, and medical device organizations to implement, validate, and operate GxP-regulated systems with sustained inspection readiness. Deep expertise in Computer System Validation (CSV), Computer Software Assurance (CSA), data integrity, regulatory remediation, and digital compliance strategy across FDA- and EMA-regulated environments. Proven leader of enterprise and cloud-based quality platforms, including ERP, QMS, LIMS, MES, CTMS, and EDC systems, across the full system lifecycle from vendor qualification and system implementation through validation execution, audit response, and system decommissioning. Recognized for designing pragmatic, risk-based CSV and CSA frameworks that integrate automation, analytics, and selective AI enablement to improve validation efficiency, strengthen data review accuracy, and support predictive compliance while maintaining regulatory rigor and inspection readiness aligned with GAMP 5, ICH E6(R2), 21 CFR Part 11, and EU Annex 11.
Overview
24
24
years of professional experience
Work History
Director, Computer System Validation
VIRSCIO
New Haven, CT
01.2023 - 01.2025
- Established enterprise lifecycle governance for CSV initiatives across preclinical systems, ensuring compliance with GLP, AAALAC, and internal SOPs.
- Authored and approved IT compliance SOPs, validation plans, URS/FRS, IQ/OQ/PQ protocols, traceability matrices, and final validation reports.
- Designed and implemented risk-based validation strategies that improved efficiency while maintaining inspection readiness.
- Optimized data integrity controls and system inventories, reducing audit risk while improving traceability and reproducibility.
- Represented IT during internal and external audits, achieving zero significant findings.
- Partnered with IT, QA, and Facilities to align compliance frameworks with organizational growth and study execution needs.
Director, Computer System Validation
TRIALSPARK (FORMATION BIO)
New York, NY
01.2021 - 01.2023
- Scaled corporate CSV and CSA programs governing regulated products and SDLC execution across GxP environments.
- Oversaw Validation Master Plans, AI Master Plans, URS/FRS, risk assessments, IQ/OQ/PQ protocols, and final reports.
- Introduced exploratory frameworks for applying AI to CSV, CSA, and data integrity to improve validation efficiency and predictive compliance.
- Built and trained a cross-functional IT Compliance team aligned with global regulatory expectations.
Senior Manager, Integrated Quality Management
FLATIRON HEALTH
New York, NY
01.2020 - 01.2021
- Defined CSV strategy supporting GxP quality programs, regulated software, and oncology research platforms.
- Established data integrity, privacy, and compliance best practices supporting real-world evidence generation.
- Served as quality lead for IT vendor oversight, inspection readiness, and enterprise risk mitigation.
- Designed and delivered training programs for electronic data capture compliance and CAPA management.
CSV / IT Quality Consultant (Clinical Quality Organization)
ADC THERAPEUTICS
New Jersey
01.2020 - 12.2020
- Created and approved GxP validation documentation supporting IT and Quality systems.
- Partnered with IT teams to align SDLC practices with global regulatory expectations.
- Managed system qualification, IT validation costs, and change control execution.
- Established procurement and vendor qualification processes (RFP/RFQ/RFI) for regulated IT solutions.
Associate Director, QC / Validation – Integrated Oncology Data Services
EISAI INC.
Woodcliff Lake, NJ
01.2019 - 01.2020
- Established formal QC and validation processes ensuring GCP compliance for oncology data platforms.
- Led validation activities for core data management tools including Pinnacle 21, automation solutions, and IRT upgrades.
- Oversaw vendor validation deliverables and supported inspection readiness initiatives.
Program Director, Risk Management & Regulatory Compliance
ORACLE HEALTH SCIENCES
Redwood City, CA
01.2017 - 01.2019
- Led compliance and security programs for regulated Oracle Health Sciences products and services.
- Partnered with corporate security, legal, and business units to ensure GDPR and global regulatory compliance.
- Supported third-party audits and regulatory inspections; served as Co-Lead for MHRA inspections.
- Developed and maintained corporate information security and validation standards.
Associate Director, GQRC GMP Validation
BRISTOL-MYERS SQUIBB
New Brunswick, NJ
01.2013 - 01.2017
- Managed a team of validation engineers providing quality oversight for facilities, utilities, and computerized systems.
- Oversaw IT audit programs supporting cGMP clinical manufacturing operations.
- Led GxP audit planning, execution, and CAPA remediation.
- Recruited, trained, and mentored validation staff aligned with corporate quality standards.
Manager, EQ-Q Computer Validation
MERCK KGAA
Darmstadt, Germany
01.2011 - 01.2013
- Implemented global CSV strategies for GxP systems across multiple sites.
- Established validation master planning, test review processes, and deviation management for global SAP implementation.
- Supported global audits and CAPA closeouts in partnership with corporate QA.
Project Compliance / Validation Lead
ORACLE ON DEMAND
Redwood City, CA
01.2010 - 01.2011
- Led 21 CFR Part 11 compliance for Pfizer e-Business Suite migration.
- Developed validation documentation for enterprise systems and system interfaces.
- Conducted internal SDLC audits and established data center quality programs.
Managing Consultant, Computer Validation
WARNER CHILCOTT
Rockaway, NJ
01.2008 - 01.2010
- Directed validation of cGMP and GCP systems across manufacturing and clinical operations.
- Led SAP ECC 5.0 validation and integration of legacy systems.
- Developed fit-for-purpose IT QMS, gap analyses, and data migration strategies.
Director, GCP / GMP QA
NOVARTIS PHARMACEUTICALS
East Hanover, NJ
01.2007 - 01.2008
- Led QA and validation for OTC and Rx-to-OTC switch programs.
- Oversaw validation of global IT systems supporting inspection readiness.
Associate Director, e-Compliance
NOVARTIS PHARMACEUTICALS
East Hanover, NJ
01.2004 - 01.2007
- Directed multi-site e-compliance initiatives integrating preclinical and clinical systems.
- Audited CROs and vendors for GLP/GCP IT compliance.
Director, Validation Services – CIBA Vision
NOVARTIS PHARMACEUTICALS
01.2002 - 01.2004
- Established corporate validation policies and remediation programs for global GxP systems.
R&D QA Validation Manager
MERIAL LIMITED (MERCK & AVENTIS)
Duluth, GA
01.2001 - 01.2002
- Managed global R&D validation for Animal Health systems including ELN, LIMS, and dosing platforms, ensuring GLP and USDA compliance.
Education
M.S. - Management – Computer & Information Systems
University of Detroit Mercy
B.S. - Sociology (Minor: Computer Science & Social Work)
St. John’s University
Skills
- TrackWise
- SAP (Health Sciences)
- Argus
- Veeva Vault (Health Sciences)
- Oracle Health Sciences Suite (Inform, IRT, Clinical One, mHealth)
- MasterControl
- Eupry
- DeltaV
- Medidata
- LIMS
- Provantis
- LabGuru
- Laboratory equipment (analyzers, microscopes, sequencers)
- AWS
- Azure
- Salesforce
- Oracle Cloud
- Egnyte
- AODocs
- Wrike
- Documentum
- Momentum
- CRFSubmit
- Central Designer
- Central Coding
- Smartsheet
- JIRA/Confluence
- Git
- Jenkins
Technical Skills
TrackWise, SAP (Health Sciences), Argus, Veeva Vault (Health Sciences), Oracle Health Sciences Suite (Inform, IRT, Clinical One, mHealth), MasterControl, Eupry, DeltaV, Medidata, LIMS, Provantis, LabGuru, Laboratory equipment (analyzers, microscopes, sequencers), AWS, Azure, Salesforce, Oracle Cloud, Egnyte, AODocs, Wrike, Documentum, Momentum, CRFSubmit, Central Designer, Central Coding, Smartsheet, JIRA/Confluence, Git, Jenkins
Websites
Professional Development Affiliations
- ISPE
- SQA
- GAMP
- Annex 11
- 21 CFR Part 11
- GCP
- GLP
- CGMP
- Six Sigma
- Novartis Development Manager (JUMP) Program
Core Specialties
FDA, EMA, MHRA, PMDA/MHLW (Japan), HIPAA, GDPR, USDA, CSV, CSA, SDLC (Waterfall & Agile), Risk Management, Data Integrity, Audit Readiness, Regulatory Remediation, SOP Development, Change Control, CAPA, Cloud Validation (AWS, Oracle, Veeva, SAP), AI-enabled compliance modeling, Real-World Evidence (RWE), Data Governance, Pharmaceuticals, Biotechnology, Animal Health, R&D, Clinical Data Management, Manufacturing, Consumer Healthcare, Medical Devices
Timeline
Director, Computer System Validation
VIRSCIO
01.2023 - 01.2025
Director, Computer System Validation
TRIALSPARK (FORMATION BIO)
01.2021 - 01.2023
Senior Manager, Integrated Quality Management
FLATIRON HEALTH
01.2020 - 01.2021
CSV / IT Quality Consultant (Clinical Quality Organization)
ADC THERAPEUTICS
01.2020 - 12.2020
Associate Director, QC / Validation – Integrated Oncology Data Services
EISAI INC.
01.2019 - 01.2020
Program Director, Risk Management & Regulatory Compliance
ORACLE HEALTH SCIENCES
01.2017 - 01.2019
Associate Director, GQRC GMP Validation
BRISTOL-MYERS SQUIBB
01.2013 - 01.2017
Manager, EQ-Q Computer Validation
MERCK KGAA
01.2011 - 01.2013
Project Compliance / Validation Lead
ORACLE ON DEMAND
01.2010 - 01.2011
Managing Consultant, Computer Validation
WARNER CHILCOTT
01.2008 - 01.2010
Director, GCP / GMP QA
NOVARTIS PHARMACEUTICALS
01.2007 - 01.2008
Associate Director, e-Compliance
NOVARTIS PHARMACEUTICALS
01.2004 - 01.2007
Director, Validation Services – CIBA Vision
NOVARTIS PHARMACEUTICALS
01.2002 - 01.2004
R&D QA Validation Manager
MERIAL LIMITED (MERCK & AVENTIS)
01.2001 - 01.2002
M.S. - Management – Computer & Information Systems
University of Detroit Mercy
B.S. - Sociology (Minor: Computer Science & Social Work)
St. John’s University